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Observational Study on Immunoadsorption (IA) in Patients With Autoantibody-Positive Post-Infectious ME/CFS

NCT07529197 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-04-14

No results posted yet for this study

Summary

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a severe, often infection-triggered disease characterized by debilitating fatigue and post-exertional malaise lasting over 14 hours, along with pain, cognitive impairment, autonomic dysfunction, and sleep disturbances. Around 10% of patients after mild or moderate COVID-19 develop Post-COVID Syndrome (PCS), and some meet ME/CFS criteria after six months. No causal treatment exists for ME/CFS or PCS; current approaches are symptomatic and rehabilitative. Given the high and increasing number of affected patients, there is an urgent need for evidence-based, standardized therapies.

Immunoadsorption (IA) is an established treatment for several autoimmune diseases. The first study demonstrating successful IA use in PCS-associated ME/CFS was published by our group in 2024. Earlier proof-of-concept studies (2018, 2020) in infection-related ME/CFS also showed symptomatic improvement in most patients.

Hypothesis:

Antibody depletion through IA improves symptoms in the majority of patients with autoantibody-positive ME/CFS and is associated with altered memory B-cell profiles before treatment.

Objective:

To observe and document symptom progression in 50 ME/CFS or PCS patients undergoing IA, and to examine whether changes in memory B-cells before treatment are linked to therapeutic response.

The study is conducted as a non-interventional observational study. IA using the TheraSorb® column (Miltenyi) is performed within its approved clinical application.

Conditions

  • Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
  • ME/CFS Following COVID-19

Interventions

DEVICE

IA with TheraSorb ® column (Miltenyi)

IA cycle is 5 days (1-2-4-6-8); the procedure follows routine clinical practice.

Sponsors & Collaborators

  • German Federal Ministry of Research, Technology, and Space (BMFTR)

    collaborator UNKNOWN

  • Weidenhammer-Zöbele Foundation

    collaborator UNKNOWN

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Carmen Scheibenbogen, Prof. Dr. · Institute of Medical Immunology, Charité - Universitätsmedizin Berlin,

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-11
Primary Completion
2027-06-30
Completion
2027-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07529197 on ClinicalTrials.gov